Amiloride Clinical Trial in Optic Neuritis

niversity of Oxford (UK)0 个研究点目标入组 46 人开始时间: 2013年5月3日最近更新: 2017年2月6日

适应症

试验速览

暂无简介。

•1. Patients with a first episode of unilateral ON
•2. Participants with an existing diagnosis of relapsing remitting MS and new onset of ON are eligible if they have not had a previous episode of ON
•3. A duration of disease of = 10 years
•4. An EDSS (Expanded Disability Status Scale) of =3
•5. No immune modulating treatment other than ß-Interferon or Glatiramer Acetate at time of recruitment
•6. Able to be randomised within 28 days of onset of visual symptoms
•7. Visual acuity of =6/9
•8. Participant is willing and able to give informed consent for participation in the study and able to comply with study visits
•9. Male or Female, aged between 18 ? 55 years.
•10. Stable dose of current regular medication for at least 4 weeks prior to study entry
•11. Female participants of child bearing potential must be willing to use two effective methods of contraception (barrier methods, hormonal methods or abstinence) during the initial 5 month treatment period of the study and for one month thereafter.
•12. Participant has clinically acceptable urea and electrolytes and estimated glomerular filtration rate (eGFR) >60
•13. Able and willing to comply with all study requirements.
•14. Willing to allow his or her General Practitioner to be notified of participation in the study.

•1. Previous diagnosis of ON
•2. Any concomitant immune suppressing or immune modulating therapy excluding ß-interferon or glatiramer acetate.
•3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
•4. Concomitant potassium supplements, angiotensin converting enzyme inhibitors, angiotensin II antagonists, cyclosporine, tacrolimus or lithium
•5. Any contra-indication to MRI ? severe claustrophobia, metal implant, pacemaker, etc.
•6. Participant who is terminally ill or is inappropriate for placebo medication
•7. Impaired renal function : eGFR =60, anuria, acute or chronic renal insufficiency and evidence of diabetic nephropathy
•8. Raised serum potassium (K+ >5.5mmol/l)
•9. Diabetes
•10. Significant concomitant eye disease in either eye that may affect diseased or fellow eye results.
•11. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant?s ability to participate in the study.
•12. Participants who have participated in another research study involving an investigational product in the past 12 weeks.

发起方

niversity of Oxford (UK)